1.First hour
• Introduction to the management of medical devices
2. Basic terms
• ISO, MDR, MDD, CSN EN, MEDDEV
3.Management of medical devices from the point of view of the hospital
• Organizational Structure and Management of Health Facilities, Medical Environment, Place, Role and Administration of Medical Devices, Legislation and Medical Devices, SÚKL, VZP, Notified Body, Notification, Accreditation
4. Health rules
• Health Safety, Adverse Events and Risks, Multidisciplinary Team, Interfaces to Healthcare Activities and Competencies
5. Biomedical technician / hospital engineer
• Position of technician / engineer, Legislation in performance of his work, Safety of medical device, Definition of other important concepts.
6.Equipment of individual workplaces
• Legislation for procurement, operation and maintenance of medical devices, Management of the assets of individual workplaces, Protection from individual sources of radiation, Patient environment, Medical device - waste
7.Metrology of medical devices
• Verification and Calibration of Meters, Units for Health, Safety Tests
8 - 9. Service support
• Legislation, Safety inspections, Disposable use of medical devices, In vitro and implantable medical devices
10 - 11.Management of quality system for manufacturers
• ČSN EN ISO 13485: 2016, Structure, Applications, Certification, Registration, Declaration of Conformity
12 - 14.Technical component
• Structure, Requirements, Content, Marking of medical devices, Usability of medical devices, Validation and verification of medical software, Clinical trials, Clinical trials, Clinical trials, Biological evaluation, Risk analysis
• Introduction to the management of medical devices
2. Basic terms
• ISO, MDR, MDD, CSN EN, MEDDEV
3.Management of medical devices from the point of view of the hospital
• Organizational Structure and Management of Health Facilities, Medical Environment, Place, Role and Administration of Medical Devices, Legislation and Medical Devices, SÚKL, VZP, Notified Body, Notification, Accreditation
4. Health rules
• Health Safety, Adverse Events and Risks, Multidisciplinary Team, Interfaces to Healthcare Activities and Competencies
5. Biomedical technician / hospital engineer
• Position of technician / engineer, Legislation in performance of his work, Safety of medical device, Definition of other important concepts.
6.Equipment of individual workplaces
• Legislation for procurement, operation and maintenance of medical devices, Management of the assets of individual workplaces, Protection from individual sources of radiation, Patient environment, Medical device - waste
7.Metrology of medical devices
• Verification and Calibration of Meters, Units for Health, Safety Tests
8 - 9. Service support
• Legislation, Safety inspections, Disposable use of medical devices, In vitro and implantable medical devices
10 - 11.Management of quality system for manufacturers
• ČSN EN ISO 13485: 2016, Structure, Applications, Certification, Registration, Declaration of Conformity
12 - 14.Technical component
• Structure, Requirements, Content, Marking of medical devices, Usability of medical devices, Validation and verification of medical software, Clinical trials, Clinical trials, Clinical trials, Biological evaluation, Risk analysis